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Ketone Supplementation in Individuals With PTSD

Primary Purpose

PTSD, Ketosis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pruvit Ketomax Ketone Salt
Placebo
Sponsored by
Augusta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Diagnosed with PTSD

Exclusion Criteria:

  • Pregnant, younger than 18 or older than 65

Sites / Locations

  • Augusta UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

6-week ketone supplementation

6-week placebo supplement

Arm Description

Participants took a ketomax ketone salt supplementation for 6-weeks. They took 2 servings per day.

Participants took a placebo supplement for 6-weeks. The placebo was calorie, sodium, and flavor-matched to the experimental supplement.

Outcomes

Primary Outcome Measures

Change in Comprehensive Metabolic Panel
Blood health marker
Change in Complete Blood Count
Blood health marker
Change in Cognitive Performance
ANAM test battery
Change in Blood Pressure
Cardiovascular health measure
Change in Urinalysis
Health measure

Secondary Outcome Measures

Change in Insomnia
Insomnia Severity Questionnaire
Change in Emotional Health
Title: 12-Item Grit Scale; Construct: measures trait-level perserverance and passion for long-term goals; the scale for each question includes the following answers to check: Very much like me, mostly like me, somewhat like me, not much like me, not like me at all; Scoring: for questions 1, 4, 6, 9, 10, and 12 the following answers receive the associated number as a score: Very much like me (5), Mostly like me (4), Somewhat like me (3), Not much like me (2), Not like me at all (1). And questions 2, 3, 5, 7, 8, and 11 receive the following points for the checked answers: Very much like me (1 points), Mostly like me (2 points), Somewhat like me (3 points), Not much like me (4 points), Not like me at all (5 points). Add up all the points and divide by 12. The maximum score on this scale is 5 (extremely gritty) and the lowest score is 1 (not at all gritty).
Change in Emotional Health
Title: Visual Analog Scales; Construct: measures the intensity or frequency of various symptoms; the scale is numerical with numbers from 0 to 10 lined horizontally and 0 indicates no symptom at all, 5 indicated neutral, and 10 indicates the highest feeling of the symptom. Symptoms asked included Hunger (0=not hungry at all, 10= very hungry), Satiety (0=don't feel full at all, 10=very full) , Mood (0= feel very down, 10= feel wonderful), Energy (0= very tired, 10=very energized), Focus (0= very distracted, 10=very focused), Alertness (0=non-coherent, 10= very aware of my surroundings)
Change in Emotional Health
Mood Disorder Questionnaire
Change in alcohol use
Alcohol Use Disorders Questionnaire
Change in PTSD
PTSD Checklist for DSM-5
Change in PTSD
Patient Health Questionnaire-9
Change in pain
Pain Outcomes Questionnaire
Change in PTSD
Adverse Childhood Experience Questionnaire

Full Information

First Posted
August 5, 2019
Last Updated
November 15, 2019
Sponsor
Augusta University
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1. Study Identification

Unique Protocol Identification Number
NCT04083352
Brief Title
Ketone Supplementation in Individuals With PTSD
Official Title
The Effects of Exogenous Ketone Supplementation or a Ketogenic Diet in Individuals With PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 30, 2016 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Augusta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine if a 6-week period of ketone salt supplementation affects physiological, emotional, cognitive, and/or behavioral health markers in individuals with PTSD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, Ketosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
6-week ketone supplementation
Arm Type
Experimental
Arm Description
Participants took a ketomax ketone salt supplementation for 6-weeks. They took 2 servings per day.
Arm Title
6-week placebo supplement
Arm Type
Placebo Comparator
Arm Description
Participants took a placebo supplement for 6-weeks. The placebo was calorie, sodium, and flavor-matched to the experimental supplement.
Intervention Type
Dietary Supplement
Intervention Name(s)
Pruvit Ketomax Ketone Salt
Intervention Description
6-week supplementation with ketone salts
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo was taken for 6-weeks and was calorie and flavor matched to the ketone salt supplement.
Primary Outcome Measure Information:
Title
Change in Comprehensive Metabolic Panel
Description
Blood health marker
Time Frame
Pre- and Post- 6-week supplemental period
Title
Change in Complete Blood Count
Description
Blood health marker
Time Frame
Pre- and Post- 6-week supplemental period
Title
Change in Cognitive Performance
Description
ANAM test battery
Time Frame
Pre- and Post- 6-week supplemental period
Title
Change in Blood Pressure
Description
Cardiovascular health measure
Time Frame
Pre- and Post- 6-week supplemental period
Title
Change in Urinalysis
Description
Health measure
Time Frame
Pre- and Post- 6-week supplemental period
Secondary Outcome Measure Information:
Title
Change in Insomnia
Description
Insomnia Severity Questionnaire
Time Frame
Pre- and Post- 6-week supplemental period
Title
Change in Emotional Health
Description
Title: 12-Item Grit Scale; Construct: measures trait-level perserverance and passion for long-term goals; the scale for each question includes the following answers to check: Very much like me, mostly like me, somewhat like me, not much like me, not like me at all; Scoring: for questions 1, 4, 6, 9, 10, and 12 the following answers receive the associated number as a score: Very much like me (5), Mostly like me (4), Somewhat like me (3), Not much like me (2), Not like me at all (1). And questions 2, 3, 5, 7, 8, and 11 receive the following points for the checked answers: Very much like me (1 points), Mostly like me (2 points), Somewhat like me (3 points), Not much like me (4 points), Not like me at all (5 points). Add up all the points and divide by 12. The maximum score on this scale is 5 (extremely gritty) and the lowest score is 1 (not at all gritty).
Time Frame
Pre- and Post- 6-week supplemental period
Title
Change in Emotional Health
Description
Title: Visual Analog Scales; Construct: measures the intensity or frequency of various symptoms; the scale is numerical with numbers from 0 to 10 lined horizontally and 0 indicates no symptom at all, 5 indicated neutral, and 10 indicates the highest feeling of the symptom. Symptoms asked included Hunger (0=not hungry at all, 10= very hungry), Satiety (0=don't feel full at all, 10=very full) , Mood (0= feel very down, 10= feel wonderful), Energy (0= very tired, 10=very energized), Focus (0= very distracted, 10=very focused), Alertness (0=non-coherent, 10= very aware of my surroundings)
Time Frame
Pre- and Post- 6-week supplemental period
Title
Change in Emotional Health
Description
Mood Disorder Questionnaire
Time Frame
Pre- and Post- 6-week supplemental period
Title
Change in alcohol use
Description
Alcohol Use Disorders Questionnaire
Time Frame
Pre- and Post- 6-week supplemental period
Title
Change in PTSD
Description
PTSD Checklist for DSM-5
Time Frame
Pre- and Post- 6-week supplemental period
Title
Change in PTSD
Description
Patient Health Questionnaire-9
Time Frame
Pre- and Post- 6-week supplemental period
Title
Change in pain
Description
Pain Outcomes Questionnaire
Time Frame
Pre- and Post- 6-week supplemental period
Title
Change in PTSD
Description
Adverse Childhood Experience Questionnaire
Time Frame
Pre- and Post- 6-week supplemental period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diagnosed with PTSD Exclusion Criteria: Pregnant, younger than 18 or older than 65
Facility Information:
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angelia M Holland
Phone
706-731-7912
Email
angholland@augusta.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Ketone Supplementation in Individuals With PTSD

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